Adolescent PCIP Randomized Feasibility Trial

Post Traumatic Stress Disorder Clinical Trial

— APCIP  

Official title:

Adolescent BREATHE Primary Care Intervention for PTSD (PCIP) Randomized Feasibility Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05088915
• Other study ID #: 21-000207
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: July 30, 2025

Study information

• Verified date: May 2024
• Source: University of California, Los Angeles
• Contact: Gray K Bowers, MA
• Phone: 310-810-8553
• Email: graybowers[@]ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There are three research questions: (1) whether the Primary Care Intervention for PTSD (PCIP) improves health outcomes; (2) whether and how the PCIP can be sustainably delivered via telehealth; and (3) how PCIP compares to treatment as usual (TAU) participants.

The mixed methods randomized feasibility trial of the protocol will be measured by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance) (n=44 patients and their care givers). We will collect data on patient, caregiver, and clinic staff participation, retention, and satisfaction (Reach and Adoption), change in hypothesized treatment mechanisms and symptoms (Effectiveness), and facilitators and barriers to intervention delivery and fidelity (Implementation). We will,

1. Assess the reach and adoption of the protocol by analyzing quantitative data on patient and clinic staff participation, retention, and satisfaction;

2. Explore the effectiveness of the protocol through medical record review, quantitative assessments at baseline and post-treatment, and semi-structured qualitative interviews at baseline and post-treatment to:

3. Evaluate the implementation of the screening and intervention protocol with post-intervention semi-structured qualitative interviews to assess facilitators and barriers to intervention delivery, quantitative fidelity scales, observation of screening, and review of intervention audio recordings to assess fidelity to the protocol and intervention process.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: July 30, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 22 Years

Eligibility

Inclusion Criteria:

1. Patient referred to the SHARK Program

2. Patients must be at least 12 years old

3. Screened for probable PTSD on UCLA RI, or at provider discretion of clinical relevancy.

4. If patient is under 18 years old, the patient's legal guardian is able and willing to provide informed consent for the patient to participate in the study;

5. Patient is able to complete study activities in English.

Exclusion Criteria:

1. Suicidal ideation with a plan within the last two weeks or a suicide attempt within the past 30 days;

2. Inability to provide informed consent or assent, and/or complete procedures in English.

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Post-Traumatic Stress Disorder in Adolescence
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Primary Care Intervention for PTSD (PCIP)
This program is adapted from the "B.R.E.A.T.H.E. - Brief Relaxation, Education and Trauma Healing: A Brief Intervention for Persons with PTSD and Co- Occurring Serious Mental Health Conditions. Treatment Program Manual and Patient Handouts (Version 3) by Kim T. Mueser, Rachael Fite, Stanley D. Rosenberg, and Jennifer D. Gottlieb.
• Treatment As Usual
Receive standard care treatment and are provided information on free or low cost mental health care referrals in the Los Angeles Area.

Locations

Country	Name	City	State
United States	University of California Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PTSD Knowledge	Changes in levels of PTSD Knowledge measured by the PTSD Knowledge Test (0-14, higher scores indicating more PTSD knowledge)	Day 0 baseline, 10 months
Primary	Change in Trauma-Related Cognitions	Changes in post-traumatic cognitions measured by the Post-Traumatic Cognitions Inventory (1-7, Higher scores indicating more post traumatic cognitions)	Day 0 baseline, 10 months
Primary	Change in Self-Reported Arousal	Changes in PTSD related arousal levels measured by the Composite Autonomic Symptom Score (COMPASS-31; 0-100 total, Higher scores indicating higher arousal)	Day 0 baseline, 10 months
Primary	Change in Stress Management Skill Use	Changes in PTSD related arousal levels measured Measure of Adolescent Coping Strategies (MACS; Total 0-102, higher scores indicate higher use of specified coping), and use of the breathing retraining techniques as measured by self-reports during in-session review.	Day 0 baseline, 10 months
Primary	Intervention Implementation and Acceptability	Qualitative interviews will include questions regarding acceptability of treatment including treatment via telehealth. Additionally, data will be collected regarding participant completion of therapy, no show rates, barriers to treatment, and attendance. Additionally, study therapists will complete qualitative and quantitative measures regarding intervention delivery feasibility and study protocols.	Day 0 baseline, 10 months
Secondary	Change in PTSD Symptoms	Changes in PTSD related symptoms measured by the UCLA Child/Adolescent PTSD Reaction Index for DSM-5 Brief Screen (total 0-44; Higher scores indicate higher likelihood of PTSD and symptom-related distress and impairment)	Day 0 baseline, 10 months
Secondary	Change in Trauma Symptoms	Changes in trauma related symptoms measured by The Child PTSD Symptom Scale (CPSS-5-SR) Self Report (total 0-80, Higher scores indicated greater symptom severity).	Day 0 baseline, 10 months
Secondary	Change in Adverse Childhood Experiences	Changes in Adverse Childhood Experiences measured by the Pediatric ACEs and Related Life Events Screener (PEARLS; 0-19, higher scores indicate higher risk of traumatic stress.	Day 0 baseline, 10 months
Secondary	Change in Depression Symptoms	Changes in depression symptoms measured by the Center for Epidemiologic Studies Depression Scale (CES-DC) Self Report (total 0-60, Higher scores indicate higher symptom severity).	Day 0 baseline, 10 months
Secondary	Change in Depression Symptoms	Changes in depression symptoms measured by the Patient Health Questionnaire (PHQ-9;0-27; Higher scores indicate higher symptoms and likelihood of depression)	Day 0 baseline, 10 months
Secondary	Change in Anxiety Symptoms	Changes in anxiety symptoms measured by the Revised Children's Anxiety and Depression Scale (RCADS) Self Report (total 0-141, Higher scores indicating higher symptom severity).	Day 0 baseline, 10 months
Secondary	Change in Functional Impairment	Changes in functional impairment measured by The Columbia Impairment Scale (C.I.S.; 0-52, Higher scores indicate greater impairment).	Day 0 baseline, 10 months
Secondary	Change in pro-inflammatory cytokine biomarkers	Changes in pro-inflammatory cytokines including TNF-a, IL-6, IFN-? and IL-1ß will be analyzed from Dried Blood Spots (DBS)	Day 0 baseline, 10 months
Secondary	Change in pro-inflammatory transcription factor activation	Changes in pro-inflammatory transcription factor activation including NF-?B/Rel will be analyzed from Dried Blood Spots (DBS)	Day 0 baseline, 10 months
Secondary	Change in Substance Use	Changes in substance use and misuse measured by CRAFFT Adolescent Substance Use Screen (0-9, Higher scores indicate higher risk for substance misuse)	Day 0 baseline, 10 months